Product NDC: | 50383-311 |
Proprietary Name: | Gabapentin |
Non Proprietary Name: | Gabapentin |
Active Ingredient(s): | 250 mg/5mL & nbsp; Gabapentin |
Administration Route(s): | ORAL |
Dosage Form(s): | SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 50383-311 |
Labeler Name: | Hi-Tech Pharmacal Co., Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA078974 |
Marketing Category: | ANDA |
Start Marketing Date: | 20110223 |
Package NDC: | 50383-311-07 |
Package Description: | 4 TRAY in 1 CASE (50383-311-07) > 10 CUP, UNIT-DOSE in 1 TRAY (50383-311-05) > 5 mL in 1 CUP, UNIT-DOSE |
NDC Code | 50383-311-07 |
Proprietary Name | Gabapentin |
Package Description | 4 TRAY in 1 CASE (50383-311-07) > 10 CUP, UNIT-DOSE in 1 TRAY (50383-311-05) > 5 mL in 1 CUP, UNIT-DOSE |
Product NDC | 50383-311 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Gabapentin |
Dosage Form Name | SOLUTION |
Route Name | ORAL |
Start Marketing Date | 20110223 |
Marketing Category Name | ANDA |
Labeler Name | Hi-Tech Pharmacal Co., Inc. |
Substance Name | GABAPENTIN |
Strength Number | 250 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |